On August 29, 2017, FDA approved Chemo Research’s NDA for benznidazole for treating children with Chagas disease and granted the sponsor a Tropical Disease Priority Review Voucher (PRV) (see FDA Press Release here). This is the first drug to treat Chagas disease, a life-threatening parasitic disease that affects …
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks an attorney to work with our drug development team. The attorney will assist our clients secure FDA approval for new drugs by leveraging our legal expertise of the approval …
In July, as reported here, the Ninth Circuit reversed the lower court’s decision to dismiss a False Claims Act (FCA) case against Gilead Sciences, Inc. Not surprisingly, Gilead timely filed a petition for rehearing or rehearing en banc with the Ninth Circuit, and several groups submitted …
On August 18, 2017, President Trump signed into law the Food and Drug Administration Reauthorization Act of 2017 (“FDARA”). In addition to reauthorizing and amending several drug and medical device provisions that were scheduled to sunset, FDARA also makes several changes to the law concerning …
On September 1, 2017, two industry trade associations, Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Innovation Organization (“BIO”), jointly filed a civil action seeking declaratory and injunctive relief against the Nevada Governor and Director of the Nevada Department of Health and Human Services …
In a settlement noteworthy to any company with a drug subject to a Risk Evaluation and Mitigation Strategy (“REMS”), on September 5, 2017, the U.S. announced a multi-million dollar civil settlement with Novo Nordisk for an alleged violation of REMS requirements for its drug Victoza …
Since the Supreme Court issued its False Claims Act (“FCA”) ruling in Universal Health Services, Inc. v. U.S. ex rel. Escobar, 136 S. Ct. 1989 (2016) courts have grappled with Escobar’s concept of FCA “materiality.” Materiality was described by the Supreme Court as a “rigorous” …
As readers of this blog may recall, last year on July 29, 2016, the National Bioengineered Food Disclosure Standard Act (“the Act”) was signed into law. This Act directs the Agricultural Marketing Service of the USDA to develop “a national mandatory bioengineered food disclosure standard” …
